BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2952070 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00389
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 8, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A RIGHT ATRIAL (RA) LEAD WARNING. THE BIPOLAR AND UNIPOLAR IMPEDANCES WERE BOTH GREATER THAN 7000 OHMS. AT THE TIME OF THE LAD REVISION THE IMPEDANCE WAS FOUND TO BE GREATER THAN 9,999 OHMS THROUGH THE DEVICE WITH NO CAPTURE AT MAXIMUM OUTPUT, WHICH WAS ALSO CONFIRMED BY THE ANALYZER. THE RA LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55675 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4524-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR